跳至主要内容
临床试验/CTRI/2021/09/036808
CTRI/2021/09/036808尚未招募不适用

A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to 0.5% levobupivacaine in lower limb surgeries: A randomised double blind study

Rohilkhand medical college and hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Onset and duration of motor and sensory blockade

研究概览

简要总结

Spinal anaesthesia is popular and commonly used worldwide. It is economical and easy to administer and thus, commonly used technique for lower limb orthopaedicsurgeries. The advantages of a minimal drug costs, awake patient and rapid patient turnover has made this the method of choice for many surgical procedures.2 Post operative pain is common problem during lower limb orthopaedic surgeries under spinal anesthesia because spinal anesthesia using only local anesthetics is associated with relatively limited duration of action, and thus early analgesic intervention is needed in the postoperative period. So number of adjuvants, such as clonidine, fentanyl, dexmedetomidine and midazolam have been studied to prolong the spinal anesthesia effect.3

Dexmedetomidine and fentanyl are promising adjuncts to provide excellent and prolonged postoperative analgesia.5 Fentanyl is a potent synthetic opioid analgesic which is short-acting and highly lipophilic. It has been commonly used as an adjuvant to bupivacaine for postoperative analgesia.1Few studies have been done with fentanyl and dexmedetomidine as an adjuvant to levobupivacaine in obstetric patients. We have not come across any study on use of fentanyl and dexmedetomidine in lower doses as an adjuvant to levobupivacaine.

Hence, in this study we propose to compare a combination of isobaric levobupivacaine with fentanyl versus dexmedetomidine in low dose for the characteristics of spinal blockade with respect to onset, duration and hemodynamic parameters and side effect.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
19.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA I or II Age between 19 to 65 years Either sex Patient posted for elective lower limb surgery.

排除标准

  • Patient refusal for procedure Patient’s contraindications to spinal anaesthesia (eg: deranged coagulation profile ) Obesity (BMI>30kg/m2) Any neuropathies Patients receiving Opioids for chronic analgesic therapy Allergy or intolerance to local anaesthetics Patients on beta-blocker or known dysrhythmia.

结局指标

主要结局

Onset and duration of motor and sensory blockade

时间窗: On Day 1

次要结局

  • Haemodynamic changes , post - op shivering and emesis(On Day 1)

研究者

发起方
Rohilkhand medical college and hospital
申办方类型
Private medical college

研究点 (1)

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